(85 days)
Not Found
No
The summary describes a mechanical suction device and does not mention any AI or ML components or functionalities.
Yes
The device is used to remove fluids from the airway or respiratory support system, which is a therapeutic intervention aimed at improving a patient's condition.
No
The device is used to remove fluids from the airway or respiratory support system, which is a therapeutic function, not a diagnostic one. It creates a vacuum to draw fluids, it does not analyze or interpret health conditions.
No
The device description clearly states it is a "Suction Unit" that "creates a negative pressure (vacuum)" and uses "disposable tubing" and a "collection canister," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to remove fluids from the airway or respiratory support system using negative pressure. This is a physical process performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description focuses on the mechanical function of creating a vacuum to draw fluids.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting substances, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical and therapeutic (removing fluids).
N/A
Intended Use / Indications for Use
The device is to be used to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection tubing that is connection val. It is for use only on the order of a physician or other licensed practitioner (e.g. EMT-field use).
Product codes
JCX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway or respiratory support system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or other licensed practitioner (e.g. EMT-field use)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
PLAXTRON INDUSTRIAL (M) SDN. BHD.
APR - 3 2012
A107
510 (K) Summary
| 5.1 Device Trade Name: | Plaxtron Suction Unit, Model 88AA51/88AA61 series |
|---|---|
| 5.2 Named and Address of | |
| Manufacturer: | PLAXTRON INDUSTRIAL (M) SDN. BHD. |
| plot 28, kawasan perusahaan, jelapang 2, ftz, | |
| ipoh, MALAYSIA 30020 | |
| Establishment | |
| Registration Number: | 8044169 |
| Contact Person: | Doris Yang |
| Engineering / Regulatory Affairs Manager | |
| Or | |
| Leo Chien | |
| General Manager | |
| Tel: 886-2-26892001 | |
| Fax: 886-2-26892468 | |
| E-mail: chtwn@ms21.hinet.net | |
| 5.3 Device Classification | |
| Names: | 1) apparatus, suction, ward use, portable, ac-powered |
| Regulation Description: | Powered Suction Pump |
| Review Panel: | General & Plastic Surgery, |
| Regulation Number: | §878.4780 |
| Classification: | Class II |
| Product Code: | 1) JCX |
| Recognized Performance | |
| Standard | ISO 10079-1:2009 (JCX) |
| 5.4 Predicate Devices: | (a) DeVilbiss Suction Unit. Model 88 00 50 & 88 00 60, |
| marketed name: Laerdal Compact Suction Unit (LCSU | |
| 3). 510(k) Number: K982304 |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Plaxtron Industrial (M) SDN, BHD % Sen Mu Technology Co., Ltd Ming-Yie Jan, Ph.D. No.15-2. Lane 26, Mincyuan 15t Road Lingya District, Kaohsiung City Taiwan 802
Re: K120065
Trade/Device Name: Plaxtron Suction Unit Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: JCX Dated: March 13, 2012 Received: March 21, 2012
Dear Dr. Ming-Yie Jan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
APR - 3 2012
2
Page 2 - Ming- Yie Jan, Ph.D.
or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set . forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor.You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for use
510(k) Number (if known): ___K120065
Device Name: Plaxtron Suction Unit
Indications for Use:
The device is to be used to remove fluids from the airway or respiratory support system. The device creates a negative pressure (vacuum) that draws fluids through disposable tubing that is connected to a collection canister. The fluids are trapped in the collection tubing that is connection val. It is for use only on the order of a physician or other licensed practitioner (e.g. EMT-field use).
Prescription Use _X (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard T. Fisher for Ned Oeylon
(Division Sign-Off)
(Division Sign-C)) Division of Surg. al. Orthopedic, and Restorative Jevices
510(k) Number_